Failure Analysis Engineer

Associate Failure Analysis Engineer

Job Snapshot

• Location: Acton, MA | Onsite

• Pay: $53.96 - $53.96/hour

• Employment Type: Contract

• Work Type: Full-time

• Experience Level: Mid Level

• Duration: 3 months

Opportunity Summary

Join the quality team at a medical device manufacturer in a hands-on engineering role investigating FDA-approved devices after they reach the market. You will test products, trace failures to their root cause, and keep the records that support quality and regulatory compliance. This is a 3-month, onsite contract in Acton, MA.
Responsibilities

• Perform product testing and failure analysis, from investigation triage through deep-dive root cause analysis
• Troubleshoot new failure modes and develop hypotheses for the cause of failures
• Review lot acceptance records and device history records, and build trend charts from quality data
• Generate and maintain quality records, including NCRs, CAPAs, training, and internal audit documentation
• Support information gathering during FDA and ISO 13485 inspections and apply Lean Six Sigma to improve process flow

Qualifications

Required

• Bachelor's degree in an engineering or scientific discipline, or equivalent experience
• Strong organization and attention to detail, with the ability to work in cross-functional teams
• Ability to operate basic hand tools

Preferred

• Electrical and mechanical background
• 2 years in a Quality function working with QSR and/or ISO 13485
• Experience in a regulated industry (medical device) or a bio-hazard or lab environment
• Knowledge of Six Sigma, Lean, SPC, ASQ, or ISO process controls
• Proficiency in MS Excel, including creating and analyzing charts
• Excellent technical writing skills

Why Join Us

• Hands-on engineering work investigating real FDA-approved medical devices
• Exposure to FDA and ISO 13485 inspections and quality system processes
• Collaborate with quality assurance engineers and cross-functional teams
• Onsite role in Acton, MA

Benefits:
Eastridge Workforce Solutions offers the following benefits, subject to applicable eligibility requirements. Use this link to learn more about benefits available to Eastridge's temporary employees. Due to the varying length(s) of temporary assignments, Eastridge Workforce Solutions' Temporary Staff are not eligible for paid time off, unless required by applicable state law in which the position is based. However, from time to time Eastridge's clients may offer additional benefits to Eastridge employees while on assignment. Information about those benefits will be communicated when applicable.

Disclaimer: The compensation and benefits information in this posting represents Eastridge's good faith and reasonable estimate of what it might pay for this position. Eastridge reserves the right to modify this information at any time, subject to applicable law.

Equal Opportunity Employer:
Eastridge Workforce Solutions is an Equal Opportunity Employer. We provide an inclusive work environment that celebrates diversity, and all qualified candidates receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, gender expression, religion, national origin, age (40 and over), disability, military status, genetic information or any other basis protected by applicable federal, state, or local laws. Eastridge Workforce Solutions also prohibits harassment or retaliation of applicants or employees based on any of these protected categories. It is our policy to comply with all applicable federal, state and local laws respecting consideration of unemployment status in making hiring decisions.

Please note that Eastridge is unable to provide visa sponsorship to applicants.

Background Checks:
Certain clients require Eastridge Workforce Solutions to perform background checks. Eastridge will consider qualified applicants with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the California Fair Chance Act, the Los Angeles City Fair Chance Ordinance, Los Angeles County Fair Chance Ordinance for Employers, and the San Francisco Fair Chance Ordinance.

Massachusetts Candidates:
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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